An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners

Breast Cancer Clinical Trial

— OPIC  

Official title:

An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342302
• Other study ID #: 200-2008
• Status: Completed
• Phase: N/A
• First received: October 15, 2009
• Last updated: April 9, 2013
• Start date: September 2008
• Est. completion date: July 2011

Study information

• Verified date: April 2011
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Breast cancer is distressing for couples in general but even more so when the illness strikes at a relatively young age. In addition to common relationship challenges, younger couples have to contend with the loss or disruption of age-appropriate goals for themselves. Presently, there are virtually no resources designed specifically to assist young couples coping with breast cancer. The purpose of this study is to develop and evaluate an online educational program geared to the unique needs and demanding schedules of young couples. The purpose of the program is to improve couples' relationships and mutual coping. Seventeen couples will take part in the 7-week program. They will complete questionnaires before and after participating to evaluate the program's helpfulness. This study will allow for the creation of a user-friendly, cost-effective tool that could help to improve the lives of all young couples coping with breast cancer in the years to come.

Description:

Women diagnosed with breast cancer at or before the age of 40 experience greater distress and poorer quality of life than women diagnosed later in life. In addition to having to cope with the range of issues common to all women with breast cancer, young women face unique challenges such as loss of fertility, concerns for young children, and interruptions to early-stage careers. The presence of adequate social support is a mitigating factor for distress in young women, and spousal support in particular has been shown to play a crucial and distinctive role in determining how well a woman adjusts to breast cancer. Unfortunately, the evidence suggests well-spouses are significantly distressed themselves, and often fall short in their attempts to meet the needs of their ill partners despite generally good intentions. Consequently, researchers have recommended that psychosocial interventions be geared to couples. However, traditional counseling interventions may not appeal to younger couples with numerous responsibilities and time constraints.

The purpose of this study is to examine the feasibility, process, and outcomes of an innovative online intervention tailored to the unique needs of young women and their partners. The primary goal is to improve partners' relationship functioning and capacity to work together as a team in relation to the illness. The secondary goal is to combat feelings of isolation by creating a community of similarly affected couples. The intervention will be delivered via a professionally moderated, password-protected website and entail: Information relevant to young couples with breast cancer; structured, interactive learning modules; and a discussion board. The online modality is particularly suited to the younger demographic targeted by this project because of its familiarity, comfort, convenience, and flexibility.

A non-randomized, repeated measures analysis of variance design will be used to test the intervention. Seventeen couples will be recruited within the Greater Toronto Area. Questionnaires assessing relationship functioning, psychological adjustment, and quality of life will be administered to participants at baseline and at completion of the 7-week program. Qualitative data from the website and treatment satisfaction questionnaire will be analyzed thematically in order to improve the intervention and its delivery.

The potential for this online intervention to fill a void in support options available to both young women with breast cancer and their partners is vast. Following completion of the project, not only will there be a demonstrable product in the website, but the investigators will have the knowledge with which to further test the intervention in a RCT. The ultimate impact of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help to improve the quality of life of all young couples coping with breast cancer, regardless of geographic location, in the years to come.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• woman has received a diagnosis of breast carcinoma within the last 18 months at any point in her treatment trajectory.

• Women must be free of known local recurrence or metastatic disease at the time of enrolment.

• Patients will have been 40 years of age or younger when diagnosed.

• Partners must be 45 years of age or younger at the time of diagnosis. - Couples must be heterosexual, and married, cohabitating, or engaged. - Participants must be fluent in English with the ability to read and write in English.

• All participants will require convenient access to a computer with internet connection.

Exclusion Criteria:

• All participants will be screened for mental illness that would interfere with their capacity to benefit from the program (e.g., suicidality, psychotic disorders, substance abuse) and excluded on this basis.

• Couples who plan to participate in couple or individual counselling during the 7-week study duration will be excluded.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Psychosocial Intervention for Couples
Intervention delivered on line

Locations

Country	Name	City	State
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)	The DAS assesses couple's level of relationship satisfaction. The DAS will be used to assess change in couples' level of relationship satisfaction following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).	pre-treatment (0 weeks) and immediate post-treatment (7 weeks)	No
Primary	Change in Personal Assessment of Intimacy in Relationships scale scores from pre (0 weeks) to post-treatment (7 weeks)	The Personal Assessment of Intimacy in Relationships scale assesses the degree of feelings of intimacy between partners. This primary outcome measure will be used to assess changes in the degree of the feelings of intimacy between partners following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).	pre-treatment (0 weeks) and immediate post-treatment (7 weeks)	No
Secondary	Mental Psychological Development Questionnaire (MPDQ)	The MPDQ assesses individual psychological adjustment.	Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).	No
Secondary	Mental Health Inventory (MHI)	The MHI assesses individual psychological adjustment.	pre-treatment (0 weeks) and post-treatment (7 weeks)	No
Secondary	Hospital Anxiety and Depression Scale (HADS)	The HADS assesses individual psychological adjustment.	pre-treatment (0 weeks) and immediate post-treatment (7 weeks)	No
Secondary	Functional Assessment of Cancer Therapy-Breast (FACT-B)	The FACT-B assesses women's individual physical and psychological adjustment to breast cancer treatment.	pre-treatment (0 weeks) and immediate post-treatment (7 weeks	No
Secondary	Breast Cancer and Relationship Measure	This measure assesses the impact of breast cancer on couple mutuality.	pre-treatment (0 weeks) and immediate post-treatment (7 weeks	No
Secondary	Treatment Expectancy and Motivation Measure (TEMM)	The TEMM assesses the degree to which individuals believe that the treatment will be helpful to them prior to starting the treatment.	pre-treatment (0 weeks)	No